NCT02183467已完成1 期
Assessment of the Effect of 5 mg and 100 mg of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Four-way Crossover Study With Moxifloxacin as Positive Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Change from baseline of the QTcI interval (individually heart rate-corrected QT interval length)
研究概览
简要总结
Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females, 21 to 50 years of age
- •Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2
- •Signed written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- •Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- •Participation in another trial with an investigational drug (≤ 60 days prior to administration or during the trial)
- •Heavy smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- •Any deviation of a laboratory value that is considered to be of clinical relevance
- •Excessive physical activities within the last week before the trial or during the trial
- •Hypersensitivity to Moxifloxacin or related drugs of these classes
- •Supine blood pressure at screening of systolic < 100 mmHg and diastolic < 60 mmHg
- •Heart rate at screening of > 80 bpm or < 40 bpm
- •Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR interval > 220 ms, QRS interval > 115 ms, QTcB or QTcF > 450 ms, or QT (uncorrected) > 470 ms
- •Subjects involved in passenger transport or operation of dangerous machines
- •For Female subjects:
- •Pregnancy or positive pregnancy test, or planning to become pregnant during the study or within 1 month of study completion Pregnancy
- •No adequate contraception during the study and until 1 month of study completion, i.e. implants, injectables, combined oral contraceptives, IUD [intrauterine device], sexual abstinence (for at least 1 month prior to enrolment), vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who have not a vasectomised partner, are not sexually abstinent or surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
- •Lactation period
研究组 & 干预措施
BI 1356, low dose
Experimental
干预措施: BI 1356, low dose (Drug)
BI 1356, high dose
Experimental
干预措施: BI 1356, high dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Moxifloxacin
Active Comparator
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Change from baseline of the QTcI interval (individually heart rate-corrected QT interval length)
时间窗: Pre-dose and 1 to 4 hours following administration
次要结局
- Mean of the QTcI change from baseline of all electrocardiograms (ECGs) taken from 1 hour to 24 hours after dosing(up to 24 hours following administration)
- Change from mean baseline of the QTcI at any point in time between 1 and 24 hours after dosing(up to 24 hours following administration)
研究者
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